Brief Summary

This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline

Completed

Started Mar 2016

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

February 11, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

March 21, 2016

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2016

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

April 19, 2019

Completed

Last Updated

April 19, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

February 11, 2016

Results QC Date

January 22, 2019

Last Update Submit

January 22, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.
Day 14
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.
Day 28

Secondary Outcomes (7)

Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
Days 14, 28
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
0 and 15 minutes after injection on Days 0, 14, 28
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
0 and 15 minutes after injection on Days 0, 14, 28
Percentage of Participants by Response to Device Satisfaction Questionnaire
Days 0, 14, 28
Tender Joint Count (TJC) Among Participants With RA
Baseline (Day 0)
+2 more secondary outcomes

Study Arms (5)

Caregivers

EXPERIMENTAL

CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.